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FDA 510(k)

COMFOR FOAM LIMB HOLDERS- SINGLE STRAP

K-Number: K963462 · 1996-11-21

ApplicantBird & Cronin, Inc.
Decision Date1996-11-21
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFOR FOAM LIMB HOLDERS- SINGLE STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Bird & Cronin, Inc.. It received FDA 510(k) clearance on 1996-11-21 under 510(k) number K963462. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFOR FOAM LIMB HOLDERS- SINGLE STRAP?

COMFOR FOAM LIMB HOLDERS- SINGLE STRAP is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Bird & Cronin, Inc.. The 510(k) number is K963462.

When did COMFOR FOAM LIMB HOLDERS- SINGLE STRAP receive FDA 510(k) clearance?

COMFOR FOAM LIMB HOLDERS- SINGLE STRAP received FDA 510(k) clearance on 1996-11-21, under 510(k) number K963462.

Who is the listed applicant for COMFOR FOAM LIMB HOLDERS- SINGLE STRAP?

The FDA 510(k) record lists Bird & Cronin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFOR FOAM LIMB HOLDERS- SINGLE STRAP?

The FDA product code for COMFOR FOAM LIMB HOLDERS- SINGLE STRAP is FMQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: FMQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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